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  • Publication
    Laws and Ethics in relation to Medical Entrepreneurship
    (2020-01-05) Iyer, Ramesh; Solomon, Jeremy
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/oibkkvvo/release/3 Some healthcare laws affect academic entrepreneurs who may also be practicing healthcare providers. Understanding the regulatory agencies and relevant laws is essential to avoiding legal entanglement with regulatory authorities and creating a successful health business venture. It is important to follow ethical standards in starting and managing a company. Ethical shortcuts may yield short-term benefits but pose substantial risk in the long run, including the potential for ethical and financial malfeasance.
  • Publication
    Negotiation Strategies
    (2019-09-30) Martin, Anthony; Max, Eric
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/d3er22l7/release/2 Preparation is key for a successful negotiation. Be sure to create a prioritized list of the objectives and try to predict the other side’s prioritized list of objectives. Which objectives align on both sides, and which do not? Research industry standards to serve as a reference point. Determine what your strongest leverage factors are and try to predict the other side’s leverage. Who has more freedom to walk away from the deal? Negotiating with startup cofounders is important for determining the fair distribution of equity and any intellectual property (IP) rights based on product conceptualization, expertise, responsibilities, commitment, and risk. Physician-scientists may negotiate with industry for sponsored research agreements, joint development agreements, or a position on the scientific advisory board. Physician-scientists may negotiate with hiring institutions for objectives like startup package funding, protected research time, start date, salary, and title.
  • Publication
    Intellectual Property Protection for Biologics
    (2019-09-27) Brewster, Megan; Singh, Pallab
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/d8ruzeq0/release/4 Biologics are a rapidly evolving area within biotechnology, and having the proper intellectual property (IP) protection is crucial to safeguarding inventions. IP protection of genetic material can be traced back to the early 1900s, though biologics themselves are fairly new. All forms of IP, including trademarks, copyrights, trade secrets, and patents can protect biologics, though most current issues have to do with patent protection. The U.S. government grants two types of protection against competition: patents through the U.S. Patent and Trademark Office (USPTO), and regulatory exclusivity through the U.S. Food and Drug Administration (FDA). There are many challenges related to obtaining IP protection of biologics, including cost, difficulties in characterization, and the uncertain nature of laws currently in place. Patent attorneys with experience in biotechnology and the university technology transfer office TTO) can work with the inventors to ensure that the biologic is properly protected.
  • Publication
    Strategic Planning and Costs of FDA Regulation
    (2019-09-30) Van Batavia, Jason; Goldenberg, Seth J
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/planning-and-costs-of-fda-regulation/release/2 The regulatory burden for medical device innovation varies based on the specific Food and Drug Administration (FDA) pathway required, and early strategic planning for this regulatory burden is critical. The regulatory strategy and milestones must be integrated with other key components of the innovation process and informed by an understanding of and/or direct communication with all the stakeholders involved, including the customer, engineering/manufacturing team, research and development team, safety/regulatory bodies, the potential payers, and investors. While it is almost never too early to initiate contact with the FDA, inquiries through 513(g) petitions or pre-submission meetings should be focused on specific questions and goals to make the most of these engagements. Regulatory assessments and consultation with experts require upfront costs, but saving time and money in the long term by designing an efficient regulatory strategy can be the difference between success and failure for the academic entrepreneur. Fundraising (private and public) must be considered in the regulatory strategy, as approximately 90% of fundraising is based on claims tied to regulatory milestones.
  • Publication
    Conducting Insightful Market Research
    (2019-09-30) Sosnowski, Michael
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/psdorj9y/release/4 Market research can complement early design work, assist with fine-tuning features and pricing, help attract investors, and suggest new directions to explore. It is critical to know where a startup is in the design process, from whom it wants feedback, and what it intends to do with the data gathered. As a general framework, it is useful to think in terms of three main blocks of the product development life cycle—early stage, middle stage, and late stage. Consider seeking help from research professionals whenever possible. There are many measurement-oriented and other practical considerations to account for, and a number of good resources a startup can turn to for help. Good research answers key objectives, and is customized to fit within a startup’s very real time and budget constraints. Addressing key questions up front will lead to more actionable results.
  • Publication
    FDA Device Regulation: 510(k), PMA
    (2019-09-25) Van Batavia, Jason; Goldenberg, Seth
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/gxp74m44/release/4 In the U.S., medical devices are classified into one of three groups based on potential risk to patients and this plays an important role in determining the appropriate FDA regulatory pathway. The three most common regulatory pathways through which the FDA clears or approves devices are: 1) exemption status, 2) 510(k), and 3) premarket approval (PMA). Early understanding of likely pathways is essential for planning device design and research strategy. All devices with more than a low or non-significant risk potential must be granted clearance, approval, or an Investigational Device Exemption (IDE) from the FDA prior to use in human subjects. Pre-submission, or Q-sub meetings, allow innovators and device companies to meet with the FDA for free and obtain feedback on the potential pathway and research protocols in an effort to have higher success with a future formal application. Early involvement of a regulatory expert or consultant can lead to a reduction in time to market and important cost savings.
  • Publication
    Nonprofit and Foundation Sponsored Research: Developing New Models of Collaboration for Research and Development
    (2019-09-27) Esparza, Erin
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/tz6ti0cb/release/3 In recent years there has been an increasing need for investigators to secure alternative sources of funding, and nonprofit organizations have become integral parts of the research and development process. Venture philanthropy is a relatively new concept of cooperation in which nonprofits not only fund research but also take a businesslike approach to product development, commercialization, and collaboration with industry partners. Potential opportunities that come with nonprofit funding can include better patient access, more early funding for research and development, and increased networking opportunities. Investigators must be prepared for potential pain points such as managing conflicts of interest, managing intellectual property, and ensuring prior art is accounted for during the application process. With proper management and transparency, involvement with a nonprofit foundation has the potential to be greatly beneficial to both the investigator and the foundation.
  • Publication
    Careers in Academia and Industry: Transitions and Challenges
    (2019-09-21) Shewale, Swapnil; Winston, Flaura
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/gub9p4a0/release/4 Start the career planning process with self-discovery and feedback from mentors. Understand the setting, culture, organizational structure, and leadership of the organizations under consideration for one’s career. Understand the expectations of potential career paths. For personal development beyond hard knowledge and skills, acquire excellent people skills and a strong network. Careers are dynamic. Maintain flexibility. Moving between environments (academia vs. industry) can be challenging, but those who successfully navigate this do so with extensive planning.
  • Publication
    SBIR/STTR Grants: Introduction and Overview
    (2019-09-27) Lee, David; Stein, Elliot; Gooneratne, Nalaka
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/1elox915/release/3 The purpose of the Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) grant mechanism is to stimulate technological innovation through facilitating private-sector commercialization of research advances. Small business entities do not need to relinquish equity in exchange for SBIR/STTR funding. A key difference between SBIR and STTR grants is that the STTR requires university participation, which is optional for the SBIR. SBIR/STTR applications can be submitted in conjunction with more traditional R01/R21 grant applications and are ideal for exploring the commercialization potential of research results.
  • Publication
    Innate Biases
    (2019-10-07) Meer, Elana
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/jsarhqw5/release/2 Entrepreneurs face a host of innate biases that inhibit their ability to make optimal and objective decisions under conditions of uncertainty. Biases include overconfidence bias, illusion of control bias, anchoring and adjustment bias, confirmation bias, curse of knowledge bias, and optimism bias. Through awareness, collaboration and inquiry, open discussion, and the deliberate challenging of consensus, entrepreneurs can mitigate these innate biases.